What is In Vitro Diagnostic Regulation (IVDR)?

In Vitro Diagnostic Regulation Definition

Medical device regulation (MDR) 2017/745 is the latest set of regulations that govern the clinical investigation, production, and distribution of medical devices in Europe. This regulation applies to medical devices that come into direct contact with humans (e.g., bandages, catheters, implants). Compliance with this regulation is mandatory for medical device companies that want to sell their products in the European marketplace. MDR 2017/745 went into effect on May 26, 2021 and replaces the EU’s previous Medical Device Directive (MDD) and Active Implantable Medical Devices Directive.

Under this new regulation, some medical devices will have stricter oversight by notified bodies, and manufacturers will need to provide more in-depth clinical data to demonstrate their safety and performance claims. In addition, the classification for some medical devices (i.e., Class I, IIa, IIb, or III) will change. Devices that meet the requirements of the regulation will receive a CE Mark.

What is In Vitro Diagnostic Regulation (IVDR)


What is the difference between IVDD and IVDR?

The IVDR provides stricter oversight in many areas as compared to the EU’s previous In Vitro Device

  • Directive (IVDD). Some key changes include:
  • Greater emphasis on the entire product lifecycle as opposed to just the pre-approval stage
  • Expanded definition of in vitro diagnostic device to include genetic testing and software
  • New risk-based classification system for in vitro diagnostic devices
  • Greater emphasis on post-market surveillance
  • More stringent requirements for clinical evidence
  • Greater supervision over notified bodies

Source: https://ec.europa.eu

What is MDR and IVDR?

The European Union’s (EU) Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), which were first published by the EU Parliament on May 5, 2017, establish new and crucial standards for medical device and in vitro diagnostic device manufacturers that market and sell their products in the EU. The new regulations provide a harmonized regulatory framework to ensure the safety and performance of devices.

Source: https://namsa.com

What does IVDR cover?

The IVDR defines IVDs as “software or systems” that are used in conjunction with the examination of specimens such as blood and tissue in order to obtain in-vitro information about “predisposition to a medical condition or a disease” or to “predict treatment response or reactions”, any of which could use algorithms.

Source: https://www.phgfoundation.org

Stay on Top of MDR, IVDR, and Surveillance Requirements

In today’s ever-evolving regulatory environment, continuous monitoring of medical device performance through post-market surveillance is crucial in ensuring compliance with standards such as MDR and IVDR.

Read our blog to learn best practices for staying on top of these requirements and how a QMS can help.